Pre-emptive Scalp Infiltration With Methylprednisolone Plus Ropivacaine for Postoperative Pain After Craniotomy

Phase 4

• Conditions: Pain, Postoperative
• Interventions: Drug: The MP/RP group; Drug: The RP group

• Registration Number: NCT04078139
• Lead Sponsor: Beijing Tiantan Hospital

Brief Summary

Pain is common for the first 2 days after major craniotomy. A majority of patients would suffer from moderate-to-severe postoperative pain after undergoing craniotomy. Inadequate analgesia induced sympathetically mediated hypertension may lead to an increased risk for post-operative complications. Adequate pain control is essential for patients' prognosis and their postoperative life quality. Pain after craniotomy derives from the scalp and pericranial muscles. Local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was not unsatisfactory due to its short pain relief duration. Pain is common for the first 2 days after major elective intracranial surgery, and the relatively short analgesic time of scalp infiltration does not seem to meet the requirements of craniotomy. Steroid such as methylprednisolone as an adjuvant to local anesthetics intra-articular injected locally reduced pain intensity after total knee arthroplasty or lumbar discectomy. However, there has not been reported about local application of methylprednisolone on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (methylprednisolone) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in adults.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-02
• Study First Submitted QC: 2019-09-02
• Study First Posted: 2019-09-04
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03
• Study Start: 2021-03-05
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 188

Inclusion Criteria

• Patients scheduled for elective craniotomy for resection of tumour under general anaesthesia;
• American Society of Anesthesiologists (ASA) physical status of I , II or III;
• Participates with an anticipated fully recovery within 2 hours postoperatively.

Exclusion Criteria

• History of craniotomy;
• Expected delayed extubation or no plan to extubate;
• Participants who cannot use a patient-controlled analgesia (PCA) device;
• • Participants who cannot understand the instructions of a numeral rating scale (NRS) 35 before surgery;
• Extreme body mass index (BMI) (< 15 or > 35);
• Allergy to opioids, methylprednisolone or ropivacaine;
• History of excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks), or use of drugs with confirmed or suspected sedative or analgesic effects;
• History of psychiatric disorders, uncontrolled epilepsy or chronic headache;
• Pregnant or at breastfeeding;
• Symptomatic cardiopulmonary, renal, or liver dysfunction or history of diabetes;
• Preoperative Glasgow Coma Scale< 15;
• Suspicion of intracranial hypertension;
• Peri-incisional infection;
• Participants who have received radiation therapy and chemotherapy preoperatively or with a high probability to require a postoperative radiation therapy and chemotherapy according to the preoperative imaging.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The MP/RP group	The MP/RP group	Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, 40mg methylprednisolone, plus 10ml saline;
The RP group	The RP group	Participates will receive peri-incisional scalp infiltration with 10ml ropivacaine 1% wt/vol, plus 10ml saline;

Primary Outcome Measures

Name	Time	Method
Cumulative butorphanol consumption within 48 hours postoperatively	Within 48 hours after the operation	All participates will receive an electronic intravenous patient-controlled analgesia (PCA) device. Participates will be advised to push the analgesic demand button if they feel pain.

Secondary Outcome Measures

Name	Time	Method
The first time to press the patient-controlled analgesia button	Within 48 hours after the operation	The first time that the participants press the patient-controlled analgesia button.
The total times that participants press patient-controlled analgesia button	Within 48 hours postoperatively	The total times that participants press patient-controlled analgesia button including effective presses and ineffective presses.
Numerical rating scale (NRS)	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery	Pain will be assessed after surgery by numerical rating scale (0 indicates no pain, 10 indicates the most severe pain imaginable).
Postoperative nausea and vomiting	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery	Postoperative nausea and vomiting (PONV) was rated by participates as: 0, absent; 1, nausea not requiring treatment; 2, nausea requiring treatment; and 3, vomiting.
Ramsay Sedation Scale (RSS)	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours after surgery	Ramsey 1: Anxious, agitated, restless; Ramsey 2: Cooperative, oriented, tranquil; Ramsey 3: Responsive to commands only If Asleep; Ramsey 4: Brisk response to light glabellar tap or loud auditory stimulus; Ramsey 5: Sluggish response to light glabellar tap or loud auditory stimulus; Ramsey 6: No response to light glabellar tap or loud auditory stimulus.
Respiratory depression	Within 48 hours after the operation	Respiratory depression is defined as a respiratory rate less than 10 breaths per minute or oxygen saturation was less than ninety percent.
The times of emergency reducing blood pressure after the operation	Within 48 hours after the operation	The criteria for treatment is determined by the participant's surgeon in charge.The times of emergency reducing blood pressure will be recording by the investigator.
Patient satisfactory scale (PSS)	At 2 hours, 4 hours, 8 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 1 month, 3 months and 6 months after surgery	0 for unsatisfactory, and 10 for very satisfied
The total consumption of opioids during the operation	During procedure	The total consumption of opioids during the operation
The length of stay	Approximately 2 weeks after the surgery	The duration of hospitalization after the operation
The World Health Organization Quality of Life (WHOQOL)-BREF	At 1 month, 3 months and 6 months after surgery	Quality of life will be measured using the World Health Organisation QoL-BREF (WHOQOL-BREF) questionnaire. The WHOQOL-BREF is a abbreviated version of the WHOQOL-100 assessment. WHOQOL-BREF is a self-report questionnaire that contains 26 items and addresses 4 QOL domains: physical health (7 items), psychological health (6 items), social relationships (3 items) and environment (8 items). Two other items measure overall QOL and general health. Each domain's mean score can range between 4 and 20 and a higher score indicates a higher quality of life. The mean score of items within each domain is used to calculate the domain score. A transformation method converts domain scores to a 0-100 scale.
The number of participants who have no butorphanol consumption	Within 48 hours after the operation	The number of participants who have not pushed the button of patient-controlled analgesia pump.
Wound Healing Score	At 1 month after surgery	Skin Healing 1: fully healed; 2: ≤3 cm in total not healed; 3: \>3 cm not healed; 4: areas of necrosis ≤3 cm; 5: areas of necrosis \>3 cm Infection 1: none; 2: ≤0.5-cm margin of redness; 3: more redness or superficial pus; 4: deep infection; not applicable Hair Regrowth 1: even regrowth along wound; 2: ≤3 cm not regrowing; 3: \>3-6 cm not regrowing; 4: \>6 cm not regrowing; not applicable

Trial Locations

Locations (1)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China